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The EU Commission released the implementation of regulation documents in regards to laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council.

 

This Document can be found here - https://eur-lex.europa.eu/eli/reg_impl/2022/1107/oj

 

This Regulation lays down common specifications for certain class D in vitro diagnostic medical devices in respect of the requirements regarding the performance characteristics set out in Section 9.1, points (a) and (b), Section 9.3 and Section 9.4, point (a), of Annex I to Regulation (EU) 2017/746.

 

• Annex I lays down common specifications for devices covered by Annexes II to XIII, as specified in that Annex.
• Annex II lays down common specifications for devices intended for detection of blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems.
• Annex III lays down common specifications for devices intended for detection or quantification of markers of human immunodeficiency virus (HIV) infection.
• Annex IV lays down common specifications for devices intended for detection or quantification of markers of human T-cell lymphotropic virus (HTLV) infection.
• Annex V lays down common specifications for devices intended for detection or quantification of markers of hepatitis C virus (HCV) infection.
• Annex VI lays down common specifications for devices intended for detection or quantification of markers of hepatitis B virus (HBV) infection.
• Annex VII lays down common specifications for devices intended for detection or quantification of markers of hepatitis D virus (HDV) infection.
• Annex VIII lays down common specifications for devices intended for detection of markers of variant Creutzfeldt-Jakob disease (vCJD).
• Annex IX lays down common specifications for devices intended for detection or quantification of markers of cytomegalovirus (CMV) infection.
• Annex X lays down common specifications for devices intended for detection or quantification of markers of Epstein-Barr virus infection (EBV).
• Annex XI lays down common specifications for devices intended for detection of markers of Treponema pallidum infection.
• Annex XII lays down common specifications for devices intended for detection or quantification of markers of Trypanosoma cruzi infection.
• Annex XIII lays down common specifications for devices intended for detection or quantification of markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

It also highlights

 

Transitional provisions

1. From 25 July 2022 until 25 July 2024, devices that are in conformity with the common technical specifications set out in Decision 2002/364/EC shall be presumed to be in conformity with the requirements regarding the performance characteristics set out in Section 9.1, points (a) and (b), Section 9.3 and Section 9.4, point (a), of Annex I to Regulation (EU) 2017/746.

During that period manufacturers of devices that are not in conformity with the common technical specifications set out in Decision 2002/364/EC shall duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.

2. From 25 July 2022 until 25 July 2024 devices that are in conformity with the common specifications set out in this Regulation shall be presumed to be in conformity with the requirements regarding the performance characteristics set out in Section 9.1, points (a) and (b), Section 9.3 and Section 9.4, point (a), of Annex I to Regulation (EU) 2017/746.

Entry into force and date of application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 25 July 2024. However, Article 3 shall apply from 25 July 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

 

While this publication helps the manufacturers with some common standards, the challenges of Regulatory Affairs still stay on the road!

Connect with our experts to get complete support for your #MedicalDevices #Diagnostics and #DigitalHealth!

 

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